Patents promote science and the useful arts by affording an important barrier to entry to the inventor in the form of a narrow monopoly over his or her inventions for the duration of the patent term. In the absence of these barriers, third parties could simply appropriate these inventions without any license from or compensation to the inventor, thereby eliminating an important incentive to invent and potentially resulting in the underproduction of innovation.
Patents alone, however, sometimes fail to provide adequate barriers, and in these cases, an innovation deficit remains. Examples of situations in which patents fail to provide such barriers include (a) consumer applications whereby infringement actions against the entire consumer class would be either impractical or devastating to the goodwill of the inventor or his or her assignee, (b) changes in market conditions unanticipated in the specific language of the patent, (c) appropriations occurring after the filing date but before the issuance of the patent, (d) infringements in jurisdictions that either fail to enforce their patents laws effectively or have no patent laws at all, (e) equipment used in the manufacturing process the infringing use of which would be difficult to discover, detect, or prove, and (f) military equipment, the design of which comprises matters of national security.
One barrier to entry available to technological innovators is secrecy. Apple, for example, has long enjoyed long market leads on new products by developing those products under strict confidentiality, and the secrecy of its cola soft drink formula has long been a source of market monopoly for the Coca-Cola Company. To the extent inventors and their assignees can keep the technological parameters of their inventions secret, significant additional barriers can be achieved to supplement those lost by inadequate patent protection.
Design secrecy can be a valuable barrier to entry for many electronic medical devices. Although the physical design features of these devices are easily discovered by reverse engineering, the most valuable features of these devices are often the program design features that direct the operation of the device. Examples of the program design features of a laser device, for example, might include the energy output, beam diameter, pulse width, repetition rate, spot separation, line separation, and number of scans of a laser device. These program design features may be embedded in the device itself or introduced into the device from an external source. If embedded in the device, these features are easily reverse engineered and discovered as well. If, however, these features are introduced into the device from an external source for only so long as necessary for each operation of the device, reverse engineering of these features would difficult, if not impossible, to achieve, and a greater degree of design secrecy would be preserved.
There is therefore a need for a method to introduce the program design features into an electronic medical device from an external source until the occurrence of a specified event, such as the passage of time estimated for the initiation and/or performance of the procedure or tampering with the device or its housing in order to make the reverse engineering of these features more difficult (or even impossible), thereby preserving a greater degree of design secrecy.